Technical Project Manager

vor 1 Woche


Zürich, Zürich, Schweiz Coopers iET AG Vollzeit

Technical Project Manager

Do you have a solid experience in qualification and validation within the biopharmaceutical industry? And now you want to step into a technical leadership role?

Here is an exciting opportunity for you to expand your knowledge.

Your responsibilities

Project Scope and Strategy Development:

  • Define the technical requirements and success criteria for the project, ensuring alignment with GMP standards, operational goals, and compliance expectations.
  • Collaborate with stakeholders to integrate operational improvements into the overall project plan.
  • Develop a comprehensive roadmap for the project lifecycle, from conceptual design through performance qualification (PQ).

Technical Leadership:

  • Act as the primary technical point of contact for the project, ensuring all mechanical adaptations and operational improvements meet required specifications.
  • Coordinate with EPCM teams to ensure alignment of engineering deliverables with technical and operational requirements.
  • Provide guidance and support to production staff implementing operational improvements.

Quality and Compliance Oversight:

  • Ensure that all project activities comply with GMP regulations and internal quality standards.
  • Collaborate with QA teams to manage GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs).

Cross-Functional Coordination:

  • Liaise with operations, maintenance, engineering, and quality teams to ensure seamless integration of mechanical adaptations into production.
  • Facilitate communication and alignment between the production staff and the EPCM to address any technical challenges or deviations.

Project Execution and Monitoring:

  • Monitor the progress of technical and operational activities to ensure milestones are met on time and within budget.
  • Conduct risk assessments and develop mitigation plans for potential project roadblocks.
  • Provide regular updates and technical reports to project stakeholders.

Testing and Qualification:

  • Lead the planning and execution of equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
  • Oversee and coordinate with validation teams to ensure the effectiveness and reliability of the implemented changes.

Your qualifications

  • Degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
  • 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on technical project management or operational excellence.
  • Proven experience working on GMP-compliant projects, including change management and qualification activities.
  • Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes in a GMP environment.
  • Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
  • Proficiency in project management tools and methodologies.


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